Inflammation and the Host Response to Injury (Trauma)

Completed

• Conditions: Multiple Organ Failure; Burns; Trauma

• Registration Number: NCT00257231
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury. The host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system. No single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time. Our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.

Detailed Description

This large-scale collaborative project provides the means to acquire the necessary new knowledge directly in humans. Knowledge will be acquired using diverse state-of-the-art genomic and proteomic technologies, a highly complex clinical, proteomic, and genomic database, as well as newly-developed, novel analytical tools to probe this complex dataset. Our analytical capabilities at the genomic and proteomic level are now rapidly evolving and our ability to link these genomic and proteomic data to pathways and functional modules will help us more closely link this cellular data to immunological processes and ultimately, to the phenotypic response (i.e., trajectory) in the injured host. As a result, potential interventions, whether through our Program or other funding mechanisms, can be more effectively designed.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-22
• Primary Completion: 2013-09
• Study Completion: 2018-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to death	Within 28 after trauma injury
Change in gene expression after trauma injury	Up to 28 days after trauma injury
Number and types of complications	Up to 28 days after trauma injury

Trial Locations

Locations (4)

Denver Health Medical Center at University of Colorado; 🇺🇸 Denver, Colorado, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Presbyterian University Hospital at University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Southwestern Medical Center at University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States